Authors
Jennifer G Robinson, Michel Farnier, Michel Krempf, Jean Bergeron, Gérald Luc, Maurizio Averna, Erik S Stroes, Gisle Langslet, Frederick J Raal, Mahfouz El Shahawy, Michael J Koren, Norman E Lepor, Christelle Lorenzato, Robert Pordy, Umesh Chaudhari, John JP Kastelein
Publication date
2015/4/16
Journal
New England Journal of Medicine
Volume
372
Issue
16
Pages
1489-1499
Publisher
Massachusetts Medical Society
Description
Background
Alirocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9), has been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy. Larger and longer-term studies are needed to establish safety and efficacy.
Methods
We conducted a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated with an acceptable side-effect profile), with or without other lipid-lowering therapy. Patients were randomly assigned in a 2:1 ratio to receive alirocumab (150 mg) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks. The primary efficacy end point was the percentage change in calculated LDL cholesterol …
Scholar articles
JG Robinson, M Farnier, M Krempf, J Bergeron, G Luc… - New England Journal of Medicine, 2015